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PK/PD Similarity of Biocon's Human Insulin R U-500 vs Humulin R U-500
NCT05413863Phase 1Completed
- Sponsor
- Biocon
- Start
- May 2022
- Primary completion
- Dec 2022
- Modality
- Recombinant Proteins and Enzymes
- Countries
- 1
01
Overview
Phase 1, randomised, double-blind trial of regular human insulin in diabetes mellitus (DM) (6 arms), sponsored by Biocon. Primary endpoints: Area under the insulin concentration curve 0-12h, Maximum observed insulin concentration and 2 more. Started May 2022; status: completed.
02
Drugs
regular human insulin
03
Conditions
diabetes mellitus (DM)
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